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Coronary Artery DiseaseL-RECORDNCT03393052

Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy

A study testing Coronary Angiography in people with Coronary Artery Disease and Vascular Access Complication, run by University Hospital of Patras at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study)… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Coronary Angiography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteGreece
Study dates
20 Jan 2017to 15 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 years
  • Written informed consent
  • Clinical indication for coronary angiography in a patient with prior history of CABG
  • Left radial artery has not been used as a graft during CABG

Who cannot join

  • Age over 90 years
  • Patient's refusal to participate in the study
  • Hemodynamic instability of the patient
  • Failure to place a sheath at the randomization access site
  • Arteriovenous fistula at the left upper limb
  • Use of right internal mammary artery as a graft during CABG
  • Creatinine clearance <30 ml/min

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • University Hospital of Patras

    Pátrai, Achaia, 26504

Other trials in Greece

About this study

This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.

Read the detailed description

Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.

Being tested
Coronary Angiography
Keywords
L-RECORD, Radial, Femoral, CABG, coronary artery bypass graft
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary AngiographyProcedure or surgery

    Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery

Study groups in NCT03393052
Study groupRoleWhat they receive
Left Radial accessActive comparatorLeft Radial approach for coronary angiography in patients with prior history of CABG surgery
Receives: Procedure: Coronary Angiography
Femoral accessActive comparatorFemoral approach for coronary angiography in patients with prior history of CABG surgery
Receives: Procedure: Coronary Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Net Procedure Time

    The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography

    Measured: 24 hours

Secondary outcomes (7)

  1. Total Procedure Time

    The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography

    Measured: 24 hours

  2. Fluoroscopy Time

    Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography

    Measured: 24 hours

  3. Dose Area Product

    Radiation DAP (mGy*cm2) during the diagnostic coronary angiography

    Measured: 24 hours

  4. Contrast Volume

    Contrast volume (ml) used during the diagnostic coronary angiography

    Measured: 24 hours

  5. Crossover access site

    Need for crossover access site, other than this of randomization

    Measured: 24 hours

  6. Major Cardiovascular Events

    Death, stroke, acute myocardial infarction

    Measured: 24 hours

  7. Vascular Complications

    Vascular access complications

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2018
  2. Study start20 Jan 2017
  3. Primary completion15 May 2018
  4. Study completion15 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03393052
Sponsor's protocol ID
5602
Acronym
L-RECORD
Status last verified
Jun 2018
First submitted
31 Dec 2017
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22.

    PubMed 26210808

  • Koltowski L, Koltowska-Haggstrom M, Filipiak KJ, Kochman J, Golicki D, Pietrasik A, Huczek Z, Balsam P, Scibisz A, Opolski G. Quality of life in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention--radial versus femoral access (from the OCEAN RACE Trial). Am J Cardiol. 2014 Aug 15;114(4):516-21. doi: 10.1016/j.amjcard.2014.05.030. Epub 2014 Jun 6.

    PubMed 25015695

  • Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16.

    PubMed 24139930

  • Louvard Y, Lefevre T, Allain A, Morice M. Coronary angiography through the radial or the femoral approach: The CARAFE study. Catheter Cardiovasc Interv. 2001 Feb;52(2):181-7. doi: 10.1002/1522-726x(200102)52:23.0.co;2-g.

    PubMed 11170325

  • Koutouzis M, Matejka G, Olivecrona G, Grip L, Albertsson P. Radial vs. femoral approach for primary percutaneous coronary intervention in octogenarians. Cardiovasc Revasc Med. 2010 Apr-Jun;11(2):79-83. doi: 10.1016/j.carrev.2009.04.107.

    PubMed 20347796

  • Baker NC, O'Connell EW, Htun WW, Sun H, Green SM, Skelding KA, Blankenship JC, Scott TD, Berger PB. Safety of coronary angiography and percutaneous coronary intervention via the radial versus femoral route in patients on uninterrupted oral anticoagulation with warfarin. Am Heart J. 2014 Oct;168(4):537-44. doi: 10.1016/j.ahj.2014.06.016. Epub 2014 Jul 3.

    PubMed 25262264

  • Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

    PubMed 21470671

  • Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.

    PubMed 19081409

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Angiography in people with Coronary Artery Disease and Vascular Access Complication, run by University Hospital of Patras at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net Procedure Time (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03393052, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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